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Ketek® Consolidated Litigation

This Litigation Has Concluded – MLG is Not Accepting New Cases

This litigation has concluded and we are proud to report that our clients' claims have been successfully resolved. The amounts of all individual client recoveries are confidential, both by settlement agreement and by attorney-client privilege. MLG is no longer accepting cases involving this product.

Our Role and Commitment to Our Clients

Along with 2 other prominent law firms, we served as Co-Lead Counsel for the Ketek® litigation that was consolidated in New Jersey State Court. In the role, we managed all of the litigation, conducting initial and ongoing discovery, taking all depositions of company witnesses, engaging in significant motion practice, engaging all necessary scientific and medical expert witnesses and assisting in producing their reports, conducting and defending expert witness depositions, developing our clients' cases, vigorously defending our clients' depositions and negotiating a confidential and substantial global settlement of all cases with the two primary defendants.

Our lead client, a young Iraqi war veteran from Ohio, was seriously injured and hospitalized with severe liver failure as a result of his exposure to the antibiotic Ketek®. His case and our efforts were chronicled on the "CBS News with Katie Couric." In addition, we worked with a former FDA Medical Officer who left the FDA as a result of his vocal and unwavering opposition to the approval of Ketek® He and Defendants' company officials were called to testify before Congress by Senator Charles Grassley who was investigating allegations of fraud and other improper conduct in the clinical trials that were used in support of the approval of Ketek® Press Clipping is available here: Ketek® PRESS RELEASE 2 8 07 - 15kb.

Overview – Sounding the Alarm about Ketek®

Ketek® (telithromycin), a recently approved antibiotic, has been associated with an increased risk of liver failure. On January 20, 2006, the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory in which the FDA warned about the use of Ketek® and potential liver toxicity. The FDA's action was in response to an article that appeared in the Annals of Internal Medicine in January, 2006.

The article – "Brief Communication: Severe Hepatotoxicity of Telithromycin: Three Case Reports and Literature Review" – described three patients who suffered "drug-induced" liver toxicity that was believed to be associated with each patient's use of Ketek®. Of these three patients, one required a liver transplant and one died. After a review of each case, the authors concluded that in all three, the liver failure was secondary to the ingestion of Ketek®

A criminal investigation of the circumstances surrounding the approval of Ketek® is currently underway. This pending criminal investigation is examining the collection and integrity of safety data that was submitted to the FDA and upon which approval was based. Serious questions have apparently arisen over the accuracy, and some cases validity, of the safety data.

Ketek® (Telithromycin)

Telithromycin – known by its brand name Ketek® - is a prescription antibiotic manufactured by Aventis Pharmaceuticals, Inc. Ketek® is in the class of antibacterial agents known as ketolides and was approved for use in the United States in April, 2004. Since then, approximately 5 million prescriptions for Ketek® have been written.

Ketek® is approved for the treatment of respiratory infections in adults. Such infections include sinus infections (sinusitis), lung infections, pneumonia and bacterial chronic bronchitis. Ketek® is thought to be stronger than traditional antibiotics and able to combat bacterial infections that have developed a resistance to the traditional antibiotics.

The use of Ketek® has recently been associated with the onset of liver disease and, in some cases, acute liver failure. An article that appeared in the January, 2006 issue of the Annals of Internal Medicine - entitled "Brief Communication: Severe Hepatotoxicity of Telithromycin: Three Case Reports and Literature Review" – reported about three patients who suffered "drug-induced" liver toxicity that was believed to be associated with each patient's use of Ketek®. Of these three patients, one required a liver transplant and one died. After a review of each case, the authors concluded that in all three, the liver failure was secondary to the ingestion of Ketek®

Ketek® and Liver Failure

According to a safety review conducted by the FDA, there have been 35 Adverse Event Reports (AERs) reports of serious liver toxicity associated with the use of Ketek®. Of these 35 cases that were reported to the FDA, 12 involved liver failure - resulting in 4 deaths – and 23 involved other serious liver injury. There are additional AER reports involving liver problems associated with Ketek® and, in May of 2006, it was suggested that a black box warning (the most serious type of warning) be added to the Ketek® label.

In the midst of these serious safety concerns, Ketek® was being tested in a pediatric population of 4,000 infants and children. The clinical trial was designed to test the efficacy of Ketek® to treat ear infections and tonsillitis. The infants and children ranged in age from 6 months to 13 years and were participating in one of 4 separate trial that were approved by the FDA.

Symptoms of Liver Disease or Failure

The liver is a vital organ that is located above the stomach in the upper right quadrant of the abdomen.

The liver consists of three main lobes and in its healthy, normal state appears dark red in color. A diseased liver often enlarges or shrink, depending on the nature of the disease.

There are many symptoms associated with the onset of liver disease or failure. Of these, the more common are:

  • Jaundice - a yellowing of the skin and whites of the eyes resulting from abnormal levels of bilirubin (a marker of abnormal liver function) circulating in the body;
  • Liver Enlargement - a swelling of the liver can produce a feeling of fullness or discomfort in the abdomen;
  • Ascites - an accumulation of fluid in the abdomen which can cause shortness of breath and abdominal discomfort;
  • Portal Hypertension - the portal vein supplies blood to the liver. Increased blood pressure (hypertension) in the portal vein is an indicator of liver disease.
  • Encephalopathy - a deterioration of brain function that can be caused by the presence of toxins that accumulate in the body as a result of liver failure.

FDA Public Health Advisory

On January 20, 2006, the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory in which the FDA warned about the use of Ketek® and potential liver toxicity. The FDA's action was in response to an article that appeared in the Annals of Internal Medicine in January, 2006. In the Advisory, the FDA stated:

  • Healthcare providers should monitor patients taking telithromycin (Ketek®) for signs or symptoms of liver problems. Telithromycin (Ketek®) should be stopped in patients who develop signs or symptoms of liver problems.
  • Patients who have been prescribed telithromycin (Ketek®) and are not experiencing side effects such as jaundice should continue taking their medicine as prescribed unless otherwise directed by their healthcare provider.
  • Patients who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare provider immediately.
  • As with all antibiotics, telithromycin (Ketek®) should only be used for infections caused by a susceptible microorganism. Telithromycin (Ketek®) is not effective in treating viral infections, so a patient with a viral infection should not receive telithromycin (Ketek®) since they would be exposed to the risk of side effects without any benefit.

Congressional and FDA Investigations

The recent safety revelations concerning Ketek® have precipitated an FDA criminal investigation into the facts, circumstances and data integrity surrounding the FDA's approval of Ketek® for sale in the United States. Although Ketek® was denied approval by the FDA prior to 2004, the drug was approved for sale in the U.S. in April 2004. The pending criminal investigation is examining the collection and integrity of safety data that was submitted to the FDA and upon which approval was based. Serious questions have apparently arisen over the accuracy, and some cases validity, of the safety data.

Separately, Senator Charles E. Grassley (R-Iowa) is reportedly considering a Senate hearing on the approval and safety of Ketek® as well as the process by which the FDA issued its approval of the drug. After conducting Senate hearings on Vioxx®, Senator Grassley is concerned that the safety issues surrounding Ketek® raise serious concerns about the FDA's drug approval process.

This Litigation Has Concluded – MLG is Not Accepting New Cases

This litigation has concluded and we are proud to report that our clients' claims have been successfully resolved. The amounts of all individual client recoveries are confidential, both by settlement agreement and by attorney-client privilege. MLG is no longer accepting cases involving this product.

Reasons To Hire

  1. Our Mission is Excellence
  2. Thorough and diligent review and analysis of your case
  3. Proven Track Record
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  5. Attention to Detail
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